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Cytori Therapeutics(NASDAQ CYTX) (NASDAQ: CYTX)
Lazard Capital Markets 8th Annual Healthcare Conference
November 16 2011November 16, 2011
Mark E. Saad, Chief Financial Officer
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Safe Harbor Statement
This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities,events or developments that we intend, expect, project, believe orevents or developments that we intend, expect, project, believe oranticipate will or may occur in the future are forward-looking statements.Such statements are based upon certain assumptions and assessmentsmade by our management in light of their experience and their perceptionof historical trends current conditions expected future developments andof historical trends, current conditions, expected future developments andother factors they believe to be appropriate.
The forward looking statements included in this presentation are also subjectThe forward-looking statements included in this presentation are also subjectto a number of material risks and uncertainties. We caution investors not toplace undue reliance on the forward-looking statements contained in thispresentation.
We would advise reading our annual report filed with the United StatesSecurities and Exchange Commission on Form 10-K for a more detailedd i ti f th i k
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description of these risks.
Investment Summary
• Large pipeline opportunity – EU chronic ischemia approval– EU acute heart attack pivotal trialEU acute heart attack pivotal trial– US chronic ischemia pilot trial– EU breast reconstruction reimbursement – Japan breast reconstruction approval
• Near term commercial business potential– Building for profitable growth
Soft tissue and translational research– Soft tissue and translational research– Grow in select emerging markets
• Established partnerships and potential future licensingEstablished partnerships and potential future licensing– $100 MM + in funding to Cytori– Multiple development and commercialization partnership prospects
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• Patent protection into mid-2020s and beyond
Investment Opportunity
Regenerative cells in the operating room in real‐timeRegenerative cells in the operating room in real‐time
Soft Tissue Repairf pAbout one hour
Cardiovascular DiseaseCytori Celution® System Regenerative cells
Celution currently approved in EuropeScalable platformSystem/Consumable model
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y35+ issued patents
Adipose Tissue: Ideal Source for Cell Therapy
Adipose Tissue: Richest source of regenerative cells in the body
Soft Tissue RepairSoft Tissue RepairLiposuction
ProcessingSoft Tissue Repair Processing
• AdipocytesM lti t t ll
Adipose Derived Regenerative Cells
• AdipocytesM lti t t ll
Adipose Tissue
• Multipotent cells• Endothelial cells• Vasc. smooth muscle cells• Tissue resident macrophages
• Multipotent cells• Endothelial cells• Vasc. smooth muscle cells• Tissue resident macrophages
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• Tissue resident macrophages• Perivascular cells
• Tissue resident macrophages• Perivascular cells
Adipose Tissue: Ideal Source for Cell Therapy
Implication: Real-time access to a patient’s own regenerative cells is possible(No lengthy and expensive cell culture or manufacturing involved)
0.545
0.25
30
15
0
Multipotent Cells in AdiposeMultipotent Cells in BM
0
Total Nucleated Cells in Adipose
6
Number of Cells (millions) per 100 mL of tissue (1/2 cup)
Soft Tissue Repair
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Soft Tissue Repair: RESTORE Procedure
Celution® approved in EU for breast reconstructionSignificant unmet medical needT l t d li i l t i l
$73
$ 26 $163
Soft Tissue RepairSoft Tissue RepairSoft Tissue RepairSoft Tissue Repair
Two completed clinical trials Safe and effectiveReimbursable
$126 $163
Clinical
Partner
‘Cell‘Cell‐‐Enriched Enriched $43 Graft’Graft’
CellsCells FatFat
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Soft Tissue Repair: RESTORE 2 Trial Outcomes
$73
$
High satisfaction rates & safety to support reimbursement efforts
Soft Tissue RepairSoft Tissue RepairSoft Tissue RepairSoft Tissue Repair
$126
80%
100%6-Mo
12-Mo
40%
60%
0%
20%
Post-Marketing Study Design• Prospective 71 patient study
Patient SatisfactionPhysician
Satisfaction
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Co-Primary Endpoints• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity
Soft Tissue Repair: Building Toward Launch
Breast Reconstruction Path to Market Access2006 – Present
Soft Tissue RepairSoft Tissue RepairSoft Tissue RepairSoft Tissue Repair
2006 Present
2006
• RESTORE 1
2007
•CE Mark for l
2008
•Cytori begins
2009
•RESTORE 2 ll
2010
•Breast
2011
•UK NIC d fInitiated in
Japangeneral processing
•RESTORE 1 data reported
RESTORE 2 trial in EU
enrollment complete
reconstruction added to CE Mark
identifies cost‐effective‐ness
•Complete RESTORE 2 data reported
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Soft Tissue Repair: Global Development Status
R l Cli i l D E l Ad iReimbursement
EU Breast Reconstruction
Regulatory Clinical Data Early Adoption(2013)
Japan Breast Reconstruction
Clinical DataRegulatory(2012)
Reimbursement(2012/2013)
Adoption
Japan Breast Reconstruction
US Parry Romberg
Clinical Data Regulatory Reimbursement Adoption
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Regulatory Clinical Data
Adoption Reimbursement
Stages of Market Access
Soft Tissue Repair: Near-Term European Market
Breast reconstruction in Europe on its own can get Cytori to profitability
Soft Tissue Repair
g y p y• Target hospitals• Focus on G5• Breast recon as entry into Operating Room
Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair
Breast recon as entry into Operating Room
Indication Status Next Milestones Market SizeGeneral processing Approved 2008;
$8.4 MM 2010 salesContinued hospital adoption @ KOL sites
Tens of millions
Breast cancer Approved July 2010 UK reimbursement $300‐400 MMBreast cancer reconstruction
Approved July 2010 UK reimbursement 2013 followed by G5
coverage
$300 400 MM
Wounds Approved July 2010 Initiation of I d d t
$500 + MM
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Independent reimbursement trial
Soft Tissue Repair: Global Revenue Potential
Celution® Consumable cartridge
Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair
Revenue Potential on Consumables alone
Assumption: One Consumable per day
C t i 15 000 h it l h b it l i t
Installed Cartridges per Price per Annual Revenue
Customer universe: 15,000 hospitals who buy capital equipment
Soft tissue est. price per consumable - $2,500 ±
Installed Systems
Cartridges per Year
Price per Cartridge
Annual RevenuePotential
100 260 $2,500 $65 MM1,000 260 $2,500 $650 MM
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1,000 260 $2,500 $650 MM10,000 260 $2,500 $6.5 Bil
Cardiovascular Disease
Dr. Fernandez-Aviles Principal Investigatorfor the PRECISE trialH G i M
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Hosp. Gregorio MaranonMadrid, Spain
Cardiac Repair: Global Development Status
Clinical Data RegulatoryE l Ad i R i b
EU Chronic Myocardial Ischemia
CE Mark Application Filed Q2 2011
g y(2012)
Early Adoption Reimbursement
EU Acute Myocardial Infarction
Clinical DataPilot complete
Pi t l b 2011Regulatory Reimbursement Adoption
EU Acute Myocardial Infarction
Pivotal began 2011
US Chronic Myocardial Ischemia
Clinical DataPRE‐IDE Q3 ‘11Initiate 2012
Regulatory Reimbursement Adoption
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Regulatory Clinical Data
Adoption Reimbursement
Stages of Market Access
Cardiac Repair: PRECISE CMI Trial
Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months20 0
Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair
20.0
19.0P<0.05 P<0.05
18.0
17.117.2
16.0
15 3
16.6
Transplant List14.015.5 15.3
N = 27 pts(6 placebo/21 treated)
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Baseline 6 Mos 18 MosADRC’sStandard of Care
(6 placebo/21 treated)
Cardiac Repair: PRECISE CMI Trial
28 Month Mortality Rate
Treated
33%
5%
MVO2:significant change at 18 months• MVO2 correlates to improved survival• MVO2 ≤ 14 = 47% 1 yr survival rate 0% 10% 20% 30% 40%
Placebo 33%
METS: significant change at 18 months
Cytori procedure safe and feasible through 18-months
Next Steps:
Applying for European ApprovalLower cardiac mortality rate:• At avg. follow up of 28 months:
- 2/6 placebo- 1/21 treated
Initiating US IDE Clinical Trial: ATHENA • Completed pre-IDE meeting with FDA
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Cardiac Repair: U.S. CMI Trial
Confirmed device designation by FDA
Pursuing IDE/PMA clinical trial
Pre-IDE meeting with FDA Q3 2011
Proposed design for “Athena” trial:• Approx. 50 patient pilot • Randomized double blind placebo controlled• Randomized, double-blind, placebo-controlled• 1o Endpoints: Safety & Efficacy
Next Steps: Next Steps: • Submit IDE application by end of year• Initiate 1H 2012
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Cardiac Repair: APOLLO Acute MI Trial
PPotential newotential new approach approach for treatment of heart attacks for treatment of heart attacks Strong Strong signals of signals of safety & efficacysafety & efficacyHigher SAE rate in ControlsHigher SAE rate in ControlsInitiated pivotal European clinical trial, ADVANCE
Diff i d ti f i f t i i i t i d i llDiff i d ti f i f t i i i t i d i ll t t d ti tt t d ti t
P < 0.05 for change from BL for ADRCs
P > 0.05 for change from BL for Placebo
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Difference in reduction of infarct size is maintained in cellDifference in reduction of infarct size is maintained in cell--treated patientstreated patients
pp<0.05 for change in infarct size for cell<0.05 for change in infarct size for cell--treated patients at 6 and 18 months (paired treated patients at 6 and 18 months (paired tt--test test comparing baseline and follow up for same patients)comparing baseline and follow up for same patients)
Cardiac Repair: APOLLO Acute MI Trial
Lower aLower abnormalbnormal ventricular beat rate in ventricular beat rate in cell groupcell groupMore significant Ventricular Arrhythmias in More significant Ventricular Arrhythmias in placeboplacebo
Higher frequency of recordings with Ventricular Higher frequency of recordings with Ventricular Premature Beats (VPB) in ControlsPremature Beats (VPB) in Controls
Higher number of VPBs per recordingHigher number of VPBs per recording in placeboin placebo
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Cardiac Repair: Significant Market Need
Estimated Market Size for Europe Alone
AMI $ 7 Billion
AMI $ 7 Billion
Annual Heart Attack Incidence (EU) 1 9 millionRegion # of Patients # of Pts (10-Yr
CMI $ 20 Billion*
CMI $ 20 Billion*
Annual Heart Attack Incidence (EU) 1.9 million
% STEMI (large heart attacks) 38%
Region (Incidence) Prevalence)UnitedKingdom
40,000 400,000
Italy 40,000 400,000Target Addressable Procedures 720,000
Est. Price per cardiac consumable $ 10,000
Italy 40,000 400,000
Germany 55,000 550,000
France 40,000 400,000p $ ,
Spain 30,000 300,000
Total G5 205,000 2,050,000Potential Healthcare Savings for CMI
LVAD + Procedure > $200 000
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LVAD + Procedure > $200,000Celution Consumable + Procedure < $50,000
Current Commercial Business
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Current Commercial Business
Build for profitable growth• Manage regions as distinct operating units• Establish beach head customers • Establish beach-head customers
Near-term catalysts • Additional country approvals
CE Mark can get Cytori to profitabilityCE Mark can get Cytori to profitability• Multi-hundred million dollar markets accessible with current approvals
E t / i i k t Enter/grow in emerging markets • India and Apollo Hospital as example• Other countries to follow
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Current Commercial Business
• Revenue growth year over year
Q t i bl• Quarters variable
• Systems driving revenue
• EU focus on reconstruction
• Emerging markets & Asia: Emerging markets & Asia:
- Aesthetics- Reconstruction
Translational research - Translational research - StemSource® cell & tissue banks
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Our Business
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Partners
Astellas Pharmaceuticals • $10 mm equity investment at $7.00• Potential for future liver disease partnershipp p
Green Hospital Supplyp pp y• Co-selling StemSource® Cell Banks in Asia
GE Healthcare• Co-distributer in select countries• Lead lender
Olympus (Japan): Manufacturing Joint Venture• Next-generation Celution® One System •ADVANCE trial
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Intellectual Property: Foundation for Protection
North America/Europe Asia Emerging Markets
US: Korea: Australia:
30+ Patents Issued Worldwide with 100 + Pending
US:CELUTION DEVICE (‘484)CELUTION PLUS ADDITIVES (‘420)CELUTION FOR CRS (‘488)STEMSOURCE DEVICE (‘115)CELUTION FUTURE GENERATIONS (‘075)
Korea:CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)
Singapore:
Australia:CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CELUTION FOR CARDIOVASCULAR (‘858)CELUTION DEVICE WITH CENTRIFUGE ORFILTER (‘937)CELUTION FUTURE GENERATIONS ( 075)
CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT(‘670)CELUTION FOR BONE (‘043)CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS(‘684)
Singapore:CELUTION DEVICE & FUTURE GENERATIONS(‘683)CELUTION FOR CARDIOVASCULAR (‘590)
China:
( )
South Africa:CELUTION FOR CARDIOVASCULAR (‘446)
Mexico:C (‘348)BEDSIDE COMPREHENSIVE
DEVICE (‘059)CELUTION OUTPUT PLUS PROSTHETICFOR BONE RELATED DISORDERS (‘716)CELLS PLUS FAT PLUS ADDITIVES (‘795)C P F (‘672)
China:CELUTION DEVICE (‘689)CELUTION FORCARDIOVASCULAR (‘104)
Japan:
CELUTION FUTURE GENERATIONS (‘348)CELUTION FOR CARDIOVASCULAR (‘775)
Russia:CELUTION FOR CARDIOVASCULAR (‘924)
CELLS PLUS FAT (‘672)
Europe:CELUTION FOR ACUTETUBULAR NECROSIS (‘834)
pCELUTION DEVICE (‘952)DEVICES FOR CELLS PLUS FAT (‘041)CLINICALLY SAFE (‘556)
India:CELUTION DEVICE (‘706)CELUTION FUTURE GENERATIONS (‘529)CELUTION DEVICE FOR TREATING WOUNDHEALING (‘580)
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Israel:CELUTION DEVICE WITH CENTRIFUGE ORFILTER (‘800)
Financials
Cash (Q3, 2011) $41 million
GE L $25 illiGE Loan $25 million
Shares Outstanding 55 millionW t ( i $ 3 80) 12 illiWarrants (average price $ 3.80) 12 millionVested Options (average price $5) 5 million
Q3 N h d i ti ti iti $7 9Q3 New cash used in operating activities $7.9
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Potential Near-Term Catalysts
Celution® One CE Mark
CE Mark for Chronic myocardial ischemia
I iti t h i di l i h i t i l i U S Initiate chronic myocardial ischemia trial in U.S.
Breast reconstruction technology evaluation in UK (reimbursement)
Celution® System approval in additional major countries
Additional partnerships
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Cytori Therapeutics(NASDAQ CYTX) (NASDAQ: CYTX)
Lazard Capital Markets 8th Annual Healthcare Conference
November 16 2011November 16, 2011
Mark E. Saad, Chief Financial Officer
30